A PHASE 2 PILOT STUDY ASSESSING IMMUNOGENICITY AND SAFETY OF IC43 IN INTENSIVE CARE PATIENTS. - IC43-201

Intercell AG0 个研究点目标入组 400 人开始时间: 2008年11月7日最近更新: 2012年3月19日

研究概览

暂无简介。

•Male and female patients aged between 18 and 80 years.
•Patients admitted to an ICU with a need for mechanical ventilation for more than 48 hours at visit 0
•At high risk for acquiring infection against P. aeruginosa (i.e. previous treatment against P. aeruginosa, diminished lung function, high probability for requiring ventilation for more than 48 hours) at visit 0.
•Patients who, as determined by the investigator, have a high probability of survival for at least 48 hours.
•In females, either childbearing potential terminated by surgery or 1 year post menopausal, or a negative pregnancy test and the willingness of practicing a reliable methods of contraception, as specified in protocol Section 6.4
•Written informed consent (e.g. by the patient or legal representative) or waiver according to the national regulations
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Known use of any other investigational or non-registered drug (except the study vaccine) within 30 days prior to IC43 vaccination at Visit 0
•Low severity of illness defined by an acute physiology score < 8 at visit 0
•Patients < 6 months post organ transplantation
•Severe thrombocytopenia or other coagulopathy which in the opinion of the investigator makes the patient unsuitable for intramuscular injection
•Pregnancy (positive pregnancy test at study entry), lactation
•Persons who have been committed involuntarily to an institution, e.g. mental health facility or prison, will not participate in the study
•Expected plasmapheresis or immunoadsorption during sutdy period (at Visit 0)

发起方